Questions arise during AstraZeneca-Oxford coronavirus vax examinations – POLITICO

To listen to the article, press the Play button

Pharmaceutical maker AstraZeneca is stepping back after experts questioned the quality of the company’s coronavirus vaccine tests.

A spokesman for the company said on Thursday that their clinical trials on the vaccine were “of the highest standard”. This included oversight by a Data and Security Observatory, which found that ‘the analysis’ [showed] protection against COVID-19, which occurs at least 14 days after administration of the vaccine. ”

The company will also submit the data to an expert diary in the coming weeks, the spokesman added.

Researchers have been raising concerns since AstraZeneca and its partner, Oxford University, announced on Monday that their chatter was about 70 per cent effective. The news was particularly welcome, as this vaccine is cheaper and easier to introduce to low- and middle-income countries than others, but experts questioned the company’s results.

The assessment released on Monday was based on data from two groups: One had nearly 9,000 people who received two full doses of the vaccine, resulting in a 62 percent efficacy, while a smaller group of 2,741 received half a dose and then a full dose. , which produced 90 percent efficiency.

Experts say this is a problem. For starters, the group that originally received half the dose of the vaccine in the UK did so by accident, the company first told Reuters.

The issue has prompted the U.S. government to investigate. Researchers like Moncef Slaoui, the outgoing leader of Operation Warp Speed ​​in the U.S., were wondering if the 90 percent efficiency rate could be related to the lack of anyone over 55 in the second experimental group.

AstraZeneca and Oxford insist that regulators be notified of the bug, which occurred when production was accelerated to produce large quantities of experiments, and agreed to continue testing this group. The company’s CEO also told Bloomberg that he plans to launch a global trial to test the half-dose.

But some researchers are still worried.

“These allegations are worrying,” said Eleanor Riley, a professor of infectious diseases at the University of Edinburgh, adding that these questions need to be answered “clearly and completely”.

Uncertainty surrounding the investigations reveals errors in which companies announce results in a press release to enthusiastic audiences and volatile financial markets. These self-reported efficiencies may resist regulatory scrutiny and gain approval for use – but mistakes made in testing can be trusted by the public.

“Trust is paramount in vaccinations, and we must not do anything that undermines that trust anyway,” Riley said.

Paul Hunter, a professor of medicine at the University of East Anglia, was among those who raised questions. In a statement, regulators said the regulators needed to review the endpoints before anyone could be sure of the efficacy needs of half-dose dosing. He added that subgroup analyzes “always come with difficulties”.

Accidental variation in dosing schedules was also one of the possible issues highlighted by Sheila Bird, a biostatistics researcher at the Medical Research Council of the University of Cambridge.

“It’s a significant complication because [the half-dose/full dose protocol] it was made by mistake, no [by] design, ”he told POLITICO on Thursday.

This and other unresolved issues related to the trial prompted Bird to refrain from Monday’s initial comments. He showed too little information about the dosing regimen in his email; how many people were randomized in each group; and how this “error” affected the analysis.

“Answers are waiting to be seen on written paper,” he wrote.

Not all researchers have been so critical. This system is not “ideal,” wrote Stephen Evans, a professor of pharmacoepidemiology at the University of Hygiene and Tropical Medicine in London. But he argued that the epidemic gave new urgency.

“In general, this applies to all COVID vaccine trials,” he wrote. “It’s not the ‘normal’ procedure for approving new vaccines – but we’re in the middle of a pandemic where there are no vaccines against the disease.”

AstraZeneca, for its part, did not answer on Thursday whether the data from all participants in the various clinical trials will be sent for peer review or only to the subgroups mentioned in Monday’s press release. He also rejected claims that the company collected cherry picking data to achieve a 70 percent efficiency rate, detailed in a long Wired article this week.

Cutting corners?

Among the issues raised by the Wired story, dosing was inconsistent throughout the studies. The control groups also did not receive the same strokes, he noted.

These questions stem from the company’s statement that it did not report data from a large-scale Phase 3 study, but reported a few subgroups from different trials around the world. This could leave half of the participants in the Brazilian trial, Wired noted in an article written by health consumer Hilda Bastian.

Perhaps the most significant concerns are that the data could have been “cherished-sorted” because AstraZeneca did not initially say which subgroups are meant for meta-analysis of the trial and when, Bastian wrote.

The 70 percent efficiency reports are “unknowable.” “We only have these numbers in order, as opposed to the trials for everyone – and they don’t explain how they got to that percentage.”

“The dosing error really raises some issues,” wrote Joy Leahy, statistical ambassador for the Royal Statistical Society, in a statement. Statistically, the more regiments tested, the more likely someone is to “produce particularly high efficiencies just because of random and random variations”.

Hunter is among those who see “supporting arguments” in subgroup analyzes. But he also questioned whether the AstraZeneca / Oxford trial “has sufficient power to analyze subgroups” as it does not appear to be included in the trial design plan.

But many experts have called for patience, noting that more data is coming.

Gillies O’Bryan-Tear, president of the Department of Politics and Communication at the Faculty of Pharmacy, said the study still involved 60,000 people in experiments around the world. “Given the efficiency we’ve seen so far [in both full and partial dose groups] … Robust efficiency is almost certain… in both groups, well above the reference value 50 [percent] which was defined as an obstacle, he said.

Even stakeholders know that these issues will soon fall into the hands of regulators, Bastian noted. But he added: “If anything other than this standard were acceptable for this vaccine, it would be easy to trigger the already widespread fears of cutting corners. A loss of confidence would affect more than this vaccination. “

We’ve updated this story.

This article is part of the following section: POLITICOpremium insurance service: Pro HealthCare. Our journalists, who specialize in drug prices, EMA, vaccines, medicines, and more, are constantly monitoring the topics that drive the health policy agenda. E-mail [email protected] for a free trial.